Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Pulse Oximeter sensor

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Study Site 1:

Inclusion Criteria:

• Has physical status between ASA 1 or 2
• Able to communicate in English

Exclusion Criteria:

• Pregnant or sexually active without birth control.
• Hemoglobin less than 11g/dL
• Known alcohol or drug abuse
• Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
• Nail polish
• Head injury with loss of consciousness within the last year
• Known neurological and psychiatric conditions.
• Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
• Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
• Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
• Baseline heart rate <50 beats per minute

Study Site 2:

Inclusion Criteria:

• Male or female
• 18-35 years of age
• Physical status of ASA I or II
• Able to read and communicate in English
• Has signed written informed consent
• If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.

Exclusion Criteria

• Age less than 18 yrs and greater than 35 years
• Hemoglobin less than 12 g/dL
• ASA physical status of III, IV, or V
• Pregnant or sexually active without birth control
• Subject has known drug or alcohol abuse
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
• Subject has experienced a head injury with loss of consciousness within the last year
• Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
• Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
• Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Raynauds Syndrome.
• Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
• Baseline heart rate < 50 bpm.
• Inability to tolerate sitting still or minimal movement for up to 90 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noninvasive Hemoglobin Sensor; All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.	Device: Pulse Oximeter sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Sensor by Arms Calculation	Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.	1-3 hours

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2009
• Primary Completion (Actual): December 31, 2009
• Study Completion (Actual): December 31, 2009

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TR19443-56044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes